当前位置: X-MOL 学术JAMA › 论文详情
Reform at the FDA—In Need of Reform
JAMA ( IF 51.273 ) Pub Date : 2020-01-14 , DOI: 10.1001/jama.2019.20538
Joshua M. Sharfstein

On December 23, 2016, the US Food and Drug Administration (FDA) announced the approval of nusinersen, the first drug for the devastating disease spinal muscular atrophy. The approval was based on an interim analysis of 82 patients in a single randomized trial; 40% of treated children improved, compared with none in the control group. The FDA had requested that the interim analysis be conducted. A press release emphasized the speed of agency action, with the review division director saying, “We worked hard to review this application quickly.”1
更新日期:2020-01-14

 

全部期刊列表>>
2020新春特辑
限时免费阅读临床医学内容
ACS材料视界
科学报告最新纳米科学与技术研究
清华大学化学系段昊泓
自然科研论文编辑服务
加州大学洛杉矶分校
上海纽约大学William Glover
南开大学化学院周其林
课题组网站
X-MOL
北京大学分子工程苏南研究院
华东师范大学分子机器及功能材料
中山大学化学工程与技术学院
试剂库存
天合科研
down
wechat
bug